All publications cited herein are incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
The rates of anal cancer among men who have sex with men (MSM) have been increasing, especially in HIV positive MSM, and are currently 80 times the rate of the general population. To screen for anal cancer and anal dysplasia both HIV infected and uninfected MSM receive a digital anal rectal examination (DARE) as well as an anal pap smear. An abnormal anal pap smear or the presence of high-risk oncogenic human papilloma virus (HPV), indicate the need for high resolution anoscopy (HRA) with biopsy. High-grade squamous intraepithelial neoplasia is a precursor lesion to anal cancer and treated with ablative, topical or surgical treatments. However, the current standard of care results in a greater than 50% reoccurrence of dysplasia. This necessitates repeated anoscopic examinations with biopsies and various ablative, topical or surgical approaches to treat these high-grade dysplastic lesions, which is unacceptable to many patients because of repeated painful examinations, biopsies and treatments. Furthermore, ablative treatments do not provide protections from the re-emergence dysplasia or HPV DNA, either through reactivation of latent HPV or acquisition of new strains of HPV DNA.
There is clearly a need in the art for improved compositions, methods, and kits for treating and preventing anal cancer and related conditions.